Regulatory Affairs Role Galway

Senior Regulatory Affairs Specialist

  • Posted Apr 22, 2022
  • Galway
  • Contract
  • BBBH25248

LSC have a great contract opportunity for a Senior Regulatory Affairs Specialist to join a Galway based medical device company.

If you have minimum 3 years' experience in the medical device industry, with at least 2 years in a position in regulatory affairs or related/equivalent fieldand are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Ensures compliance with regulatory agency regulations and interpretations.
  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Provides regulatory advice to project teams.
  • Guides conformance with applicable regulations in product development, support of claims and label content.
  • Defines data and information needed for regulatory approvals. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Assist in the development of product reimbursement strategies. Lead applications for product reimbursements in line with company strategies.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
  • Experience of inspection by an external agency, such as the FDA.
  • Ability to work well under deadlines and pressure.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Apply via this advert or contact Pawel Jurkiewicz at +353 214771329 if you have any more questions about this opportunity!

This could be the perfect project for you! Apply online and we’ll be in contact shortly

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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